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Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy) (MEDICO-LIBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03901196
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : February 9, 2021
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
Evaluate the feasibility of performing a multi-elemental imaging analysis of lung specimens from patients with ILDs, with an technology named LIBS (Laser Induced-Breakdown Spectroscopy)

Condition or disease Intervention/treatment
Interstitial Lung Disease Sarcoidosis Idiopathic Pulmonary Fibrosis Diagnostic Test: Elemental analysis

Detailed Description:

There is a major health problem due to the environmental and occupational related exposures to mineral particles, metals, and dust. The impact on health is considerable in terms of prevalence, morbidity and healthcare costs. Pathologists rarely report the presence of a possible mineral or metal-related etiology in a specimen by lack of available and convenient technology. Therefore, several respiratory diseases are considered idiopathic.

Interstitial lung disease (ILD), also known as diffuse parenchymal lung disease (DPLD) is a group of lung diseases affecting the interstitium (the tissue and space around the air sacs of the lungs). In France, 15.000 new cases of ILD are diagnosed each year. ILD may be classified according to the cause. Idiopathic ILD are ILD of unknown causes. The most frequent idiopathic ILD are sarcoidosis and idiopathic pulmonary fibrosis (IPF).These two diseases are the core topic of the present study since they may relate to important mineral or metal exposure.

The overall goal of this MEDICO-LIBS study is to evaluate the feasibility of using a laser-induced breakdown spectroscopy (LIBS)-based instrument to image(ie, identify, localize and possibly quantify) metals within selected human specimens with ILDs.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy) : a Feasibility Study
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : January 22, 2023
Estimated Study Completion Date : January 22, 2023

Group/Cohort Intervention/treatment
Interstitial Lung Disease
Ex : sarcoidosis, IPF
Diagnostic Test: Elemental analysis
LIBS multi elemental analysis of the specimen

Primary Outcome Measures :
  1. Generation of multi-elemental images in tissues with LIBS [ Time Frame: Within a month after reception of the biopsy by the analytical laboratory ]
    Evaluation of the feasibility of collecting and describing LIBS multi-elemental images of lung specimens originating from patients with ILDs

Secondary Outcome Measures :
  1. Description of elemental distribution in the specimens [ Time Frame: Within a month after reception of the biopsy by the analytical laboratory ]
    Comprehensive chemical characterization of both endogenous and exogenous elements for each specimen

  2. Interpretation of the elemental maps [ Time Frame: Within a month after reception of the biopsy by the analytical laboratory ]
    Understanding of the elemental distribution according to the clinical data

  3. Comparison of the elemental distributions with results of other mineralogical investigations [ Time Frame: Within a month after reception of the biopsy by the analytical laboratory ]
    Only for patients who previously benefited from other mineralogical investigations (eg, SEM-EDX), comparison of mineralogical analysis obtained with the elemental distributions obtained with LIBS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with Interstitial Lung Disease

Inclusion Criteria:

  • Patient with ILD
  • Patient informed, and agreed to participate

Exclusion Criteria:

  • Patient opposed to participating in the study.
  • Patient without available specimen.
  • Patient under legal protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03901196

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Contact: Benoit Busser, PharmD, PhD +33 4 76 76 89 39

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Grenoble Alpes University Hospital Recruiting
Grenoble, France, 38043
Contact: Vincent Bonneterre, MD, PhD   
Contact: Sébastien Quetant, MD   
CHRU de LILLE Not yet recruiting
Lille, France, 59000
Contact: Cecile Chenivesse, MD, PhD   
CHU de Lyon HCL - GH Sud Not yet recruiting
Lyon, France, 69310
Contact: Nathalie Freymond, MD   
Hôpital Louis Pradel Not yet recruiting
Lyon, France, 69677
Contact: Vincent Cottin, MD, PhD   
Sponsors and Collaborators
University Hospital, Grenoble
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Principal Investigator: Benoit Busser, PharmD, PhD Grenoble Alpes University Hospital
Publications of Results:
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Responsible Party: University Hospital, Grenoble Identifier: NCT03901196    
Other Study ID Numbers: 38RC18.134
2019-A00070-57 ( Other Identifier: ID RCB )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Laser Induced Breakdown Spectroscopy
Multi elemental imaging
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lymphoproliferative Disorders
Lymphatic Diseases